Regulations

05Feb 2024

EU, Regulations Cubicdesignz Comments: 0

EU Declaration of Conformity

The Declaration of conformity (DoC) is one of the key documents within technical documentation. Technical documentation is necessary for manufacturers as this is a detailed record that provides essential information on the design, manufacture, and operation. EU Declaration of Conformity is signed by the manufacturer to declare that the products comply with the EU requirements. By signing it, the manufacturer takes full responsibility for the product’s compliance with the applica...

05Feb 2024

Regulations Cubicdesignz Comments: 0

UK Declaration of Conformity

After Britain leaving the EU, there have been many changes in the regulations regarding medical devices. An example of this is the UK’s Declaration of Conformity. UK Declaration of Conformity (DoC) is a technical document that products with UKCA marking should possess. The information needed on the Declaration of Conformity (DoC) is largely the same as what was required on an EU Declaration of Conformity. According to UK’s guidance on UKCA marking, manufacturers are recommended to keep...

05Feb 2024

EU, Registrations, Regulations Cubicdesignz Comments: 0

Requirements of Technical Documentation EU MDR

Technical documentation should contain details of the medical device in a clear, organized, readily searchable and unambiguous manner. It should be provided with all medical devices irrespective of the device class and to be kept updated throughout the product life cycle. Technical documentation is to be prepared according to the requirements given in Annex II of EU MDR 2017/745. Requirements of Technical Documentation as per Annex II 1. Device description and specification, including varia...

05Feb 2024

Regulations Cubicdesignz Comments: 0

Requirements of Technical Documentation EU MDR

Technical documentation should contain details of the medical device in a clear, organized, readily searchable and unambiguous manner. It should be provided with all medical devices irrespective of the device class and to be kept updated throughout the product life cycle. Technical documentation is to be prepared according to the requirements given in Annex II of EU MDR 2017/745. Requirements of Technical Documentation as per Annex II Device Description and Specification, including variants...

05Feb 2024

Regulations Cubicdesignz Comments: 0

IMDRF Regulation on SaMD

The SaMD definition statement should include a clear and robust statement about intended use, including the following: The term “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. SaMD is software that carries out one or more medical tasks. If it might be incorporated with a piece of hardware, the software performs a medical function. The international me...

05Feb 2024

EU, Regulations Cubicdesignz Comments: 0

Cybersecurity for medical devices in Europe

EU Cybersecurity laws for Medical devices are advancing, and the use of software medical devices is also increasing daily. The increased interconnection of medical devices to computer networks and technological convergence have made devices and software programmes vulnerable to mishaps. The importance of protecting patient data from cyber-attacks is now well recognised. With the advancement of software as a medical device, proper regulations must be established to ensure the safety and security...

05Feb 2024

Regulations Cubicdesignz Comments: 0

Cybersecurity for Medical Devices – FDA and EU MDR Perspective

FDA –Food and Drug Administration The revolution in the digital sector has resulted in the Internet of Things (IoT), Software as a Medical Device (SaMD), Internet of Medical Things (IoMT) and other connected devices permeating the healthcare environment, both in hospital and home, has ended up with the possibility of cyberattacks and intrusions against the connected medical devices and the networks to which such a device is connected. Most Medical devices are connected to the Internet, hospita...

05Feb 2024

EU, News, Regulations Cubicdesignz Comments: 0

Risk Management of medical devices under MDR

All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device’s specific risks to a patient. Under EU MDR 2017/745, risk management is a continuous and iterative process. Manufacturers are expected to plan, document, and implement risk management strategies in this process. These strategies may either eliminate the risk or mitigate the overall severity of the risk. Medical Device Risk- Definition ...

05Feb 2024

EU, Regulations Cubicdesignz Comments: 0

The ‘Blue Guide’ on EU product rules implementation 2022

The amended ‘Blue Guide’ on the application of the product rules 2022’ (“Blue Guide”) was released by the European Commission on June 29, 2022. The Blue Guide allows a better understanding of EU product regulations and their uniform and coherent application across various sectors throughout the EU single market. The Blue Guide has undergone significant changes, including the definition of new terms, the addition of information on which economic actors will be responsible for compliance...

05Feb 2024

Regulations Cubicdesignz Comments: 0

Article 61 Clinical Evaluation in the EU MDR

Article 61 Clinical Evaluation The MDR reinforces the clinical data and evaluation process (article 61 and Annex XIV), and the manufacturer must confirm the device’s conformity to fundamental health and safety requirements using reliable clinical data and evaluation. The clinical evaluation establishes the device’s safety and capacity to fulfil its intended function. It also evaluates adverse side effects and determines whether the benefit-risk ratio is acceptable. Manufacturers must plan, c...

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